EU Greenlights Moderna Covid Vaccine

07.01.2021 - Moderna’s mRNA-based Covid-19 vaccine will become the second to be administered in Europe. The European Commission granted a conditional marketing authorization to the US biotech on Jan. 6, shortly after the candidate was approved by the European Medicines Agency (EMA).

The Pfizer-BioNTech vaccine, also based on mRNA, was granted authorization two weeks ago and is currently being administered in the 27 EU member states. EMA’s human medicines committee (CHMP) said it had thoroughly assessed Moderna’s quality, safety and efficacy data and recommended the authorization by consensus.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, EMA’s executive director. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by World Health Organzation (WHO).”

Moderna’s Phase 3 clinical trials with 30,000 people showed that its vaccine was about 94% effective at preventing Covid-19 in people aged 18 to 94, who had no sign of previous infection, and 90.9% effective in  high-risk participants, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.

As is the case for the Pfizer-BioNTech shot, Cooke said the EMA will continue to monitor safety and effectiveness of the vaccine as it is administered, through the EU pharmacovigilance system and additional studies by the company and European authorities. An assessment report with details of the evaluation and the full risk management plan, will be published “within days,” she said.

Moderna and NIH to study second dose delay merits

Moderna and the US National Institutes of Health (NIH) meanwhile are evaluating whether supplies of the vaccine could be doubled by halving the dose, a strategy that is also being eyed in the UK for other vaccines, but is highly controversial among scientists. The Moderna shot has not been approved in Britain.

Moncef Slaoui, who heads the US Warp Speed action to accelerate the development of Covid vaccines for Americans, has also come out in favor of such a move. Those who received two 50-mcg doses of Moderna's shot, compared to the standard 100-mcg regimen, showed an "identical immune response," he asserted.  Reports noted, however, that as this data stems from an early Phase 2 study, developer would either have to reassess its Phase 2 or start a new trial before a change could be considered.

While the WHO has not weighed in on the US plans as yet, commenting on British plans to stretch tight supply, it said the organization said second doses of Pfizer and BioNTech's vaccine should be administered within 21 to 28 days as recommended, or – in exceptional circumstances –  within six weeks at the latest. There is” very little data from the trials that underpin this type of recommendation.”

In another move toward improving distribution, the US state of New York said it will start fining hospitals that fail to dispense their allocated doses within a week of receiving them and bar them from being supplied in future doses. Florida officially is allocating doses to hospitals that dispense them quickest, while reports are circulating that the board of one high-priced nursing home has offered vaccination slots to wealthy donors.

German health minister Jens Spahn rejected the notion of delaying the second dose in order to speed up the process after the UK approved such a move last week. Spahn suggested he would await the green light from BioNTech-Pfizer before taking such a measure. 

He also said that Germany is working alongside BioNTech to  start up a new production site in Marburg, which could be open as early as next month, in order to boost global supplies. 

Meanwhile, Spahn said the German government would acquire 50 million doses of the Moderna vaccine following the European Union's approval of the jab. 

Author: Dede Williams, Freelance Journalist